BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATIVE FLUID

    MDR report key: 1023762 · Received March 25, 2008

    Report

    Report Number
    1062336-2008-00002
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 25, 2008
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS AN ACCIDENTAL SPLASH UNRELATED TO THE DESIGN OR FUNCTION OF THE DEVICE. IN ADDITION, THE DEVICE PRODUCT INSERT CONTAINS THE FOLLOWING WARNING, "AVOID SPLASHING OR GENERATING AEROSOLS. OPERATORS SHOULD USE APPROPRIATE HAND, EYE AND CLOTHING PROTECTION." IN THIS EVENT, THE OPERATOR WAS NOT WEARING ANY EYE PROTECTION.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN WAS DISCARDING USED SYRINGING PIPETTES AND WAS STRUCK IN THE EYE WITH A DROPLET OF PRESERVATIVE FLUID. THE TECHNICIAN WAS NOT WEARING PROTECTIVE EYEWEAR. THERE WERE 24 SAMPLES IN THE BATCH BEING PROCESSED, ONE OF WHICH WAS FROM AN HIV POSITIVE PATIENT. THE TECHNICIAN WAS TREATED WITH HIV PROPHYLAXIS MEDICATIONS AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATIVE FLUID LIQUID BASED PAP SMEAR COLLECTION LEA TRIPATH IMAGING, INC. NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention